MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT® FN PLUS

Catalog Number	410852
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomerieux of bottle leakage from a cracked bact/alert® fn plus blood culture bottle (reference 410852).The customer reported the bottle was initially ejected and that the calibrator was also ejected soon afterward.The customer reloaded the calibrator but it was ejected again.The patient bottle that was ejected had a crack and the operator who handled the bottle did not have gloves on.The customer confirmed that an incident form was filled out at the hospital.No additional information was provided regarding any treatment for the operator or any impact to patient results.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was initiated due to a customer reporting bottle leakage from a cracked bact/alert® fn plus blood culture bottle (reference 410852).The investigation could not examine the bact/alert® fn plus bottle manufacturing records, as the customer did not report the bottle lot number.Historical review of complaint data did not identify a specific trend for broken bottles.The investigation is unable to determine the root cause of the broken bottle as there is not enough information provided to evaluate the issue.The customer should follow the instructions in the bottle instructions for use [ifu] to examine bottles for damage prior to use.In the future, providing pictures, instrument logs/backup, lot numbers is recommended to aide in evaluating the complaint.It is also recommended to wear gloves and personal protective equipment when handling inoculated bottles as indicated in the bottle's ifu.

• Brand Name: BACT/ALERT® FN PLUS
• Common Device Name: BACT/ALERT® FN PLUS
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe drive; durham NC 27712
• MDR Report Key: 8032422
• Report Number: 3002769706-2018-00228
• Device Sequence Number: 16469428
• Product Code: MDB
• UDI-Device Identifier: 03573026357917
• UDI-Public: 03573026357917
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 410852
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1